Optimizing Attention and Sleep Intervention Study: A Pilot RCT to Compare Parent Behavioral Interventions With and Without Sleep Strategies Delivered in Pediatric Primary Care for Preschool-aged Children at Risk of Childhood ADHD

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms. The main aims are to: Aim 1: Demonstrate the acceptability, feasibility, and appropriateness of the sleep focused PBI (SF-PBI) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for ADHD. Aim 2: Examine change in target engagement (sleep) and ADHD symptoms among preschool-aged children at elevated risk for ADHD receiving SF-PBI compared to standard PBI.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 5
Healthy Volunteers: f
View:

⁃ Parent/Caregiver:

• (1) Legal guardian is at least 18 years of age

• (2) Reads and speaks English

⁃ Child:

• (1) 3-5 years of age

• (2) Caregiver report of 4 or more ADHD symptoms

• (3) Caregiver reports child's sleep as a moderate or serious problem

• (4) English speaking

• (5) Child receives care from participating pediatric primary care office

Locations
United States
Pennsylvania
Children's Community Pediatrics Bass Wolfson, Cranberry
RECRUITING
Cranberry Township
Children's Community Pediatrics GIL Murrysville
RECRUITING
Monroeville
Children's Community Pediatrics Neshannock
NOT_YET_RECRUITING
New Castle
Children's Community Pediatrics Shenango
RECRUITING
New Castle
Children's Community Pediatrics Bass Wolfson, Squirrel Hill
RECRUITING
Pittsburgh
Children's Community Pediatrics GIL East Liberty
RECRUITING
Pittsburgh
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Heather M Joseph, DO
liebherrh@upmc.edu
4122465338
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 50
Treatments
Active_comparator: Brief Parent Behavioral Intervention
A brief parent behavioral intervention with evidenced based strategies for treatment of ADHD.
Experimental: Sleep-Focused Parent Behavioral Intervention
A modified version of the brief parent behavioral intervention that specifically targets sleep disrupting behaviors.
Sponsors
Leads: University of Pittsburgh
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov